Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mead Johnson Nutrition
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01584245
First received: April 23, 2012
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.


Condition Intervention
Cow's Milk Allergy
Other: Amino Acid formula

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Allergic manifestations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight loss within the past 4 weeks
  • Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
  • Birth weight greater than or equal to 1500 grams
  • Solely enteral fed
  • Infants with at least one persistent allergy symptom
  • No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
  • Signed informed consent

Exclusion Criteria:

  • History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
  • Metabolic disease requiring special attention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584245

Contacts
Contact: Nancy Moore 812-483-1847 nancy.moore@mjn.com

Locations
France
Centre médical Recruiting
Boulogne Billancourt, France
Principal Investigator: Delphine de Boissieu, MD         
Centre médical Recruiting
Boulogne Billancourt, France
Sub-Investigator: Marie-Pierre Cordier, MD         
Hôpital Saint Vincent de Paul Recruiting
Lille, France
Sub-Investigator: Nicolas Kalach, MD         
Hôpital Armand Trousseau Recruiting
Paris, France
Sub-Investigator: Patrick Tounian, MD         
Hôpital Necker Enfants Malades Recruiting
Paris, France
Sub-Investigator: Florence Campeotto, MD         
Médecine Infantile 1 Recruiting
Vandoeuvre Lés Nancy, France
Sub-Investigator: Pascale Dumond, MD         
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Delphine de Boissieu, M.D. Centre médical
  More Information

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01584245     History of Changes
Other Study ID Numbers: 6009
Study First Received: April 23, 2012
Last Updated: July 18, 2014
Health Authority: France: Comité de protection des personnes

Additional relevant MeSH terms:
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014